Hospital epidemiologists and the IRB: Two views

Viewpoint 1:
Silvia Munoz-Price

During the past few years, my hospital has experienced high rates of Clostridium difficile infections especially in one inpatient unit. This situation is of major concern to Hospital Administration, the Quality Department, the Infection Control Department, as well as medical and nursing leadership. As the Hospital Epidemiologist, my main duty is to better understand the pathophysiology of the infection control problems so that interventions can be tailored to our specific needs. My initial questions in this particular situation focused on where the acquisition of C. difficile strains were occurring. Are patients acquiring C. difficile at home, in the outpatient clinic, or in the inpatient units? If they were already colonized upon admission to the inpatient unit, then that would certainly explain why infection control bundles had been ineffective in controlling this problem for the past year. Or is it that the hospital environment is acting as a reservoir for C. difficile due to inappropriate disinfection? In order to answer these questions, we started a quality Improvement project, testing the unit with DAZO, culturing the environment, and performing active surveillance cultures of consecutive patients on admission and weekly thereafter. These stool surveillance cultures aimed to detect asymptomatic carriers presenting from the community.

After a couple of months of pursuing these initiatives, I am now getting questioned in regards to my lack of IRB approval. Pondering this issue, to me it is clear that as a hospital epidemiologist I am mandated to investigate the answers to the above questions. Should I get IRB approval ahead of time before each of these projects? I think the answer should be no. If we are not testing any invasive procedure or drugs, but rather we are trying to understand how to prevent infections in our patients, we should not be required to get an IRB approval ahead of time. I do think the IRB should be involved once we determine that the data collected merits publication. THAT is the time when hospital epidemiologists should get the IRB involved. Otherwise, we handicap ourselves on the investigations that we do as part of our duties. Another situation that should warrant IRB approval from the start is multicenter studies of infection control interventions, given that their intent from the start is to publish the findings.

It is true that our job duties fall in the gray zone between quality and research, and some of us tend to publish a great deal of what is done as part of our paid job. However, we should always be guided by this initial question: Is the primary goal of the project to help my patients and my hospital or is the primary goal to publish the results? If it is the former, I say do not ask for permission to do your job. If it is the latter, then by all means, IRB approval is necessary.

Viewpoint 2:

Mike Edmond

I agree with Silvia that this is a problematic issue for hospital epidemiologists, and also agree that the interventions she describes should not require submission to the IRB. My view is that you need IRB approval if your intent is to answer a research question, and that you don’t need IRB approval if the intent is to do quality improvement, particularly if you are implementing interventions that have already been shown to be effective in published studies. I don’t think the intent to publish results has anything to do with the decision to submit for IRB review. For example, if I roll out chlorhexidine bathing to the entire hospital and find that our infection rates fall (or increase, or even if nothing happens at all), I don’t think I need IRB approval regardless of whether I choose to publish the results. On the other hand, if I want to do a trial of chlorhexidine bathing and randomize hospital units to test the hypothesis that chlorhexidine reduces infection rates, that would require IRB approval.

If you would like the US Department of Health and Human Services official opinion on what constitutes research and requires IRB review, I have attached their algorithms below. Once you go through those algorithms, it will all be crystal clear!

 

"Question everything you're told"

It's graduation time on many campuses. In fact, we missed many folks at SHEA's spring meeting last weekend because they were attending a family member's or student's graduation.

Twenty-five years ago, when I graduated from the University of Michigan, I was lucky enough to have a good seat for Lawrence Kasdan's (Raiders of the Lost Ark, Empire Strikes Back, The Big Chill, Star Wars: The Force Awakens) speech, which I've posted above. Many things he said on that day, I still carry with me. For example, I suspect that folks that "question everything they're told" are more likely to choose a career in infectious diseases.

A few highlights (full text here):

"Here’s what I can tell you: the hardest thing in the world is to let yourself know what you know. Why? Because life is noisy. Everything we’re told, everything about the way we’re raised and educated and bombarded by our culture makes noise. And that noise makes it very hard to hear the ticking of our own hearts"

"Did you know that eating a double sausage pizza at midnight, on the night before a final, may not be the smartest thing to do....nutrition wise?"

Safety and efficacy of nontoxigenic C. difficile spores in preventing recurrent CDI

Lead Author: Dr. Dale Gerding

We have written and spoken often on the efficacy of fecal transplants in treating recurrent C. difficile infections. Wouldn't it be great if there was a way to prevent recurrent CDI in the first place? What if "good" C. difficile strains that lack toxin production genes could be used to out compete bad strains and prevent recurrent CDI?

There is a new study just published in JAMA that evaluates the safety and efficacy of a nontoxigenic C. difficile strain M3 (VP20621; NTCD-M3) in preventing recurrent CDI in those patients initially treated with metronidazole and/or oral vancomycin. In the four-arms of the phase 2, double-blind placebo-controlled trial they compared patients given oral liquid formulation of NTCD-M3, 10^4 spores/day for 7 days (n = 43), 10^7 spores/day for 7 days (n = 44), or 10^7 spores/day for 14 days (n = 42), or placebo for 14 days (n = 44).

Recurrent CDI occurred in 13/43 (30%) of placebo patients and only 14/125 (11%) of patients treated with NTCD-M3 patients (odds ratio [OR], 0.28; 95% CI, 0.11-0.69; P = .006). Fecal colonization with the NTCD-M3 strain was reported in 69% of treated patients and was associated with lower recurrence: 2/86 (2%) recurrence if colonized vs. 12/39 (31%) recurrence in treated but uncolonized patients (OR, 0.01; 95% CI, 0.00-0.05). Side effects such as abdominal pain, diarrhea and serious side effects were actually higher in the placebo groups. If this smaller study's findings are confirmed in larger trials, we may just have a new treatment for the prevention of recurrent CDI. Very cool.

Check out the video interview with lead author Dr. Dale Gerding, another related video and the JAMA Associate Editor's podcast covering this article and other important studies.

The new healthcare epidemiologist

The April issue of Infection Control and Hospital Epidemiology has a white paper on skills and competencies for the healthcare epidemiologist. True to form, the paper reflects the rather timid approach that SHEA never seems able to shake. As a disclaimer, I should state that I sit on the Board of Trustees of SHEA, and I’m not saying anything in this post that I haven’t shared previously.

While the paper mentions that the healthcare epidemiologist should have an understanding of quality improvement and safety, and is a valuable partner to the Chief Quality Officer (CQO), what it should state is that the healthcare epidemiologist is uniquely qualified to be the CQO. Infection prevention was the first QI program ever to emerge and remains better developed than QI and patient safety. Many healthcare epidemiologists have advanced degrees in public health or epidemiology, and the skill set is directly transferable to QI and safety. Increasingly hospitals are developing CQO positions, but very few of these positions are held by healthcare epidemiologists. In some cases, CQOs may not have a true appreciation for the value of the healthcare epidemiologist, and some of us fear that healthcare epidemiologists as we know them may ultimately be replaced by less trained individuals. Interestingly, Dick Wenzel published a book on quality improvement in 1992, but unfortunately, SHEA chose to remain confined to infectious adverse outcomes rather than expanding into the quality realm.

So my recommendations are these:

1. SHEA should move aggressively and quickly into the quality and safety space.
2. To broaden the skillset of the healthcare epidemiologist, SHEA needs to sponsor education on leadership, implementation science, human factors engineering, Six Sigma, Lean, and other quality improvement and patient safety topics.
3. As much as I hate to talk about certification given the absolute mess the American Board of Internal Medicine has made of our certification processes, I continue to believe that healthcare epidemiology will never be seen as a valid entity until there is certification. Once certification occurs, then it becomes possible to build the requirement for a healthcare epidemiologist into payer’s conditions of participation, hospital accreditation, and hospital quality rankings. We need to make the healthcare epidemiologist indispensable. 
4. SHEA’s journal, Infection Control and Hospital Epidemiology, should specifically solicit papers focused on noninfectious adverse outcomes, quality improvement and patient safety. 

In a nutshell, SHEA should define the role of the healthcare epidemiologist more broadly, which in the long run will help its members more easily achieve leadership positions in hospitals and have a seat at the table when important decisions are made.

Graphic: Stratabridge